Replies to post #5523 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

IMHO, there was a degree of timing placed into the trial.

The timing is a bit off, so the world has to wait.

If the Pseudo-progression enrollment didn't start until 2011 or so, then it may be the 72 spaces they added to the trial are for the them.

Do some very simple math.

Ultimately 240 in the main body.
Ultimately 112 events required for final analysis
66 required for 1st interim analysis.

72 in the alternative group (pseudo-progression)
Ultimately 33 events "desired" for final analysis.
19 "desired" for 1st interim analysis.

If you met the primary endpoint in the main body, the pseudo-progression group is not an afterthought. They are just as important, and you would want to analyze the results before you unblind the trial. You would not want to neglect this very important group, and even though they are analyzed separately, ultimately you would want to also determine how both groups did as a whole.

If you were simply going to continue the main body of the trial, you could simply do that and analyze the pseudo-progression group at the second interim analysis for the primary group. You would not wait for the pseudo-progression minimum events at the 1st interim analysis in this situation.

This would explain why they are telling us efficacy data analysis is pending.

Finally, there would be simply no reason to halt the trial for futility at the 1st interim unless the results on the primary group were showing a statistical detriment (which would be a safety issue) to the patients. Thus the safety continuation is more meaningful at the 1st interim than perhaps any other time when you have a very safe treatment.

[foxhound02]

I have read the following statement 552 times.

The DSMB's review of the efficacy data is still pending.

There are two ways to read this. I will just re-write in plane language that remove's the need for two versions.

1) The DSMB's review of the efficacy data is still not finished.

2) The DSMB's review of the efficacy data is complete and the trial will be terminated early, pending FDA guidance.

They could have worded it the first way, and should have if true. If the second statement is true, they would not reveal a closed door discussion with FDA; they threw us the best bone they could at this time.